Non-invasive Positive Pressure (NPPV ) for Severe Stable Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Non-invasive Positive Pressure Ventilation for the Treatment of Severe Stable Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02499718
• Other study ID #: GRID-201506
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2015
• Last updated: July 15, 2015
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2015
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Zhou LuQian, Doctor
• Phone: +86-15622236759
• Email: zhlx09[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Assessment of the effect and safety of noninvasive positive pressure ventilation for severe stable chronic obstructive pulmonary disease

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• clinically stable, hypercapnic GOLD stage IV COPD, aged 18 years or older, baseline arterial carbon dioxide pressure (PaCO2) of 6.7 kPa (50 mmHg) or higher and a pH higher than 7·35, measured after at least 1 h rest in a sitting position.

Exclusion Criteria:

• thorax or the lung other than COPD

• No smoking or Cigarette=10/day

• obesity with a bodymass index (BMI) =40 kg/m²

• malignant co-morbidities,severe heart failure (New York Heart Association stage IV),unstable angina, and severe arrhythmias.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypercapnic Respiratory Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

Device:
• BiPAP mode
Noninvasive ventilator

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Disease	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease	Dongguan People's Hospital, Second Affiliated Hospital, Sun Yat-Sen University, Southern Medical University, China, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe Respiratory Insufficiency (SRI) Questionnaire		1 year	Yes
Secondary	Blood gas analysis		1 year	Yes
Secondary	Pulmanory function		1 year	Yes
Secondary	Baseline Dyspnea Index/Transition Dyspnea Index		1 year	Yes
Secondary	Chromic Respiratory Questionnaire		1 year	Yes
Secondary	Chronic Obstructive Pulmonary Disease (COPD) Assessment Test		1 year	Yes
Secondary	6 Minute-Walking Distance and Borg Score		1 year	Yes
Secondary	The frequency of exacerbation		1 year	Yes
Secondary	The frequency of readmission		1 year	Yes
Secondary	The frequency of ICU readmission		1 year	Yes
Secondary	survival rate		1 year	Yes